Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127217311 | 12721731 | 1 | I | 20160306 | 20160830 | 20160907 | 20160907 | EXP | IT-MINISAL02-372706 | IT-MYLANLABS-2016M1037194 | MYLAN | 0.00 | Y | 0.00000 | 20160907 | MD | IT | IT |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127217311 | 12721731 | 1 | PS | KETOROLAC | KETOROLACKETOROLAC TROMETHAMINE | 1 | Intravenous (not otherwise specified) | 30 MG, PRN | Y | 78299 | 30 | MG | INJECTION | ||||||
| 127217311 | 12721731 | 2 | SS | PARACETAMOLO SALF | ACETAMINOPHEN | 1 | Intravenous (not otherwise specified) | 10 MG, PRN | Y | 0 | 10 | MG | SOLUTION FOR INJECTION | ||||||
| 127217311 | 12721731 | 3 | SS | CEFAZOLIN | CEFAZOLIN | 1 | Intravenous (not otherwise specified) | 2 G, TOTAL | 0 | 2 | G | POWDER FOR SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127217311 | 12721731 | 1 | Analgesic therapy |
| 127217311 | 12721731 | 2 | Analgesic therapy |
| 127217311 | 12721731 | 3 | Antibiotic prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127217311 | 12721731 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127217311 | 12721731 | Acute kidney injury | |
| 127217311 | 12721731 | Renal tubular necrosis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 127217311 | 12721731 | 1 | 20160303 | 20160306 | 0 | |
| 127217311 | 12721731 | 2 | 20160303 | 20160306 | 0 | |
| 127217311 | 12721731 | 3 | 20160303 | 20160303 | 0 |